NCT07621796尚未招募3 期
Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 660
- 试验地点
- 1
研究概览
简要总结
The study will randomize patients with acute ischemic stroke and Direct Oral AntiCoagulants (DOAC) ingestion within 48 hours from enrollment (but otherwise eligible for thrombolysis) to administration of intravenous tenecteplase vs. placebo (1:1).
Participants will be enrolled at NIH StrokeNet sites across the US and followed for 90-days.
The primary aim is to determine the efficacy of intravenous tenecteplase (TNK) vs placebo among acute ischemic stroke patients and to determine the safety of TNK among acute ischemic stroke patients within 4.5 hours of last known well who used DOAC within 48 hours prior to thrombolysis. Efficacy and safety endpoints will be the focus of this proposed Phase III study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years or older) with a suspected acute ischemic stroke and clearly disabling deficits
- •Presenting within 4.5 hours of last known well
- •Able to initiate intravenous thrombolysis within 4.5 hours of last known well
- •On recent DOAC therapy (dabigatran, apixaban, rivaroxaban, edoxaban) and known last dose taken within 48 hours from thrombolysis.
排除标准
- •Current or history of intracerebral hemorrhage
- •Non-disabling deficits
- •Bleeding disorder (e.g. hemophilia) or advanced liver disease or known INR > 1.7 within 6 hours
- •Use of therapeutic low molecular weight heparin or therapeutic dose heparin with elevated PTT
- •ASPECTS < 6 or clear hypodensity on CT suggestive of completed infarct
- •Advanced kidney disease (eGFR < 30 ml/min)
- •Known or suspected aortic dissection
- •Known or high suspicion for infective endocarditis
- •Surgery within 2 weeks
- •Intracranial or intraspinal surgery within 3 months
- •Active internal bleeding or gastrointestinal or urinary tract hemorrhage within 3 weeks
- •Intracranial neoplasm, arterio-venous malformation, or cavernous malformation
- •Major head trauma or ischemic stroke within 3 months
- •Known thrombocytopenia (platelets < 100,000)
- •Planned endovascular treatment within 30 minutes of study drug administration (i.e., consent, randomization and administration of study drug must occur at least 30 minutes prior to groin puncture; standard care is not to be delayed and patients in whom endovascular therapy will start sooner will not be enrolled)
- •Comorbid condition with life expectancy of less than 3 months
- •Any condition that precludes thrombolytic therapy as determined by site principal investigator
- •Pregnancy
研究者
研究点 (1)
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